The present invention is related to the oral delivery of an active agent. More particularly, it is a closure system for an active agent delivery device. The active agent delivery device comprises a lumen containing an active agent in the form of discrete units through which a fluid is drawn when suction is applied to one end of the device.
Tablets, capsules, caplets and many other types of devices have been used for oral delivery of active agents. These forms are relatively easy to manufacture and convenient for use in the hospital or other institutional settings or at home. Many different types of active agents have been incorporated into such dosage formsxe2x80x94ranging from analgesics to antibiotics to hormones.
There are patients that, because of age or infirmity, have difficulty swallowing solid oral dosage forms. According to Kikendall et al., Digestive Diseases and Sciences 28:2(1983), there were 221 cases documented between 1970-1982 of tablet and capsule induced esophageal injury. The most commonly implicated drugs were tetracycline (108 cases), emepronium bromide (36 cases), potassium chloride (16 cases) and ferrous salts (12 cases).
In view of the above, various approaches have been proposed whereby swallowing of a large solid system is avoided as is described in the following patents and applications which are all incorporated by reference herein.
U.S. Pat. No. 2,436,505 to DuRall describes a pill douser for administering medicines in liquid form or in pills or tablets. The device has a bowl at the top for containing the medicine and a tube that can be submerged in a liquid held in a drinking glass. The liquid is drawn upward for administering the liquid and any pill or tablet present in the bowl.
U.S. Pat. No. 2,867,536 to Mead et al. describes an improved drinking straw where a soluble flavoring material is contained within an annular space contained within an inner and an outer tube. The inner tube has a bore through which liquid can be drawn. During use, the upper and lower caps are removed, the flavoring material is emptied into the liquid and the flavored liquid is drawn up through the inner tube and into the mouth.
U.S. Pat. No. 3,610,483 to Visconti describes a dispensing device for liquid medication that is formed in the shape of a straw. A predetermined dose of liquid medication is loaded into the straw which is then capped at both ends until the medication is dispensed when a patient removes the caps and sucks air into the device.
U.S. Pat. No. 4,581,013 to Allen is directed to a doser for orally administering a medication. A tube with a removable closure and a radially extending plate supports a solid medication and permits passage of a stream of liquid. The tube is fitted on top of a straw that is placed into a liquid.
U.S. Pat. No. 4,792,333 to Kidder describes a tamper proof package for containing and orally administering a solid substance. A tube has two portions that are separated by a supporting and confining means that supports and confines the solid substance but permits fluid flow. The ends of the tube are hermetically sealed.
U.S. Pat. No. 4,981,468 to Benefiel et al. is directed to a unit dosage form for delivering a therapeutic agent in free-flowing form. A slanted grid supports the dose between two ends of a tube.
PCT patent application Ser. No. PCT/US96/11812 describes an oral active agent delivery system comprising a hollow chamber that contains discrete units of active agent. A fluid passing retainer prevents release of the discrete units but permits fluid entry into the chamber. The retainer is transportable with the fluid entering the system.
A variety of other oral delivery systems have been described. These include a medicated pacifier (U.S. Pat. No. 5,123,915 to Miller et al.) and a lollipop type device for delivery of a solid medicament (U.S. Pat. No. 5,223,259 to Lackney). None of these devices or the devices described previously provide for the delivery of a solid medicament into the oral cavity as a bolus dose, while avoiding the difficulties inherent in swallowing a solid system such as a tablet or a capsule or the shelf-life problems encountered when a medicine is dissolved or dispersed in a fluid, where the integrity of the dose of active agent is maintained and where inadvertent swallowing of the device, or portions thereof, is avoided. Furthermore, there is a need for simple, easy to use, and reliable closure systems for active agent delivery systems.
Accordingly, in one aspect the present invention is directed to a closure system for preventing spillage from an active agent delivery device. The device comprises a first tubular member with a first end suitable for placement in a liquid and a second end suitable for placement in the mouth of a patient and contains an active agent in the form of discrete units. The closure system comprises a deformable closure means that upon deformation is adapted to open the first end of the tubular member and allow transport of active agent therethrough. The deformation of the closure means preferably is irreversible so as to serve as an indication of prior use or misuse of the delivery device.
In another aspect, the closure system comprises a second tubular member that concentrically surrounds the second end of said first tubular member. A protuberance on the first end of the second tubular member extends towards the first end of the first tubular member. The second end of the second tubular member is closed to prevent spillage of the active agent.
In still another aspect, the invention is a closure system for preventing spillage from an active agent delivery device where the closure system comprises a second tubular member that has an inner portion and an outer portion. The inner portion extends inside the second end of the first tubular member of the delivery device and comprises a cutting edge and the outer portion comprises a rupturable membrane.
In yet another aspect, the invention is a closure system for preventing spillage from an active agent delivery device, where a tubular member has a first end and a second end. The second end is closed and further is in part removable in order to permit a patient to suck up the active agent from the second end of the device after the first end has been inserted into a fluid.
In a further aspect, the invention is a closure system for preventing spillage from an active agent delivery device, where a tubular member has a first end and a second end. The second end comprises a valve that is normally closed and is openable in order to permit a patient to suck up the active agent from the second end of the device after the first end has been inserted into a fluid.
In still another aspect, the invention is a method for preventing loss of an active agent from an active agent delivery device. The method comprises providing a tubular member with a first end and a closed second end, opening the second end in order to expose the active agent and placing the second end in the mouth to deliver the agent by sucking. The portions of the device that remain following delivery are too large to be swallowed by the patient.